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「日本における傷病 ¡を中心とする ... - jspe.jp

1 1 2 3 4 5 6 7 8 9 10 11 2 12 *13 * 1 London School of Hygiene and Tropical Medicine 2 3 4 5 6 7 8 9 10 11 12 MSD 13 NPO NPO 113-0034 1-2-13 4F E-mail: 2 < > (DB) 2017 10 26 2018 4 1 GPSP DB

2 <抄録> 【目的】医療情報データベース(db)の活用が薬剤疫学、その他の分野で進んでおり、2017年10月 26 日に公され 2018 年4 月1 日に実施されるgpsp 省令の改正でも医療情報db を用いた調

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Transcription of 「日本における傷病 ¡を中心とする ... - jspe.jp

1 1 1 2 3 4 5 6 7 8 9 10 11 2 12 *13 * 1 London School of Hygiene and Tropical Medicine 2 3 4 5 6 7 8 9 10 11 12 MSD 13 NPO NPO 113-0034 1-2-13 4F E-mail.

2 2 < > (DB) 2017 10 26 2018 4 1 GPSP DB DB DB DB TF 2016 7

3 Valid* (1) DB (2) (3) (4) (5) (6) (7) (8) 8 8 Strom Pharmacoepidemiology 5 41 100 (1) DB (2) DB population-based (3)ICD (4) (5) (6) (7) (8)

4 % 3 DB DB Diagnosis Procedure Combination (DPC) DB DB ICD-10

5 All possible cases DPC DPC DB DB 4 5 1.

6 2. (1) (2) (3) 3. (1) (2) (3) (4) (5) (6) (7) (8) 4. (1) (2) DPC (3) (4) (5) 5. 1. 4 2. 3.

7 All possible cases 2 2 . 1 2 3 4 5: 6 1. (claims data) (electronic health records, EHR electronic medical records, EMR) routinely collected data (1) 1990 2012 4 11 0411 1 0411 2 2017 10 26 16 171 Good Post-marketing Study Practice.

8 GPSP (1) 2012 / Pharmacovigilance Plan (2) Primary Data Collection 2016 7

9 7 2. (1) (validation) (validity) (3, 4) (CSV) (5) (2)

10 International Classification of Diseases Version 10 (ICD-10) (6) (confounder) (exposure)


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